DHEA Against Vaginal Atrophy - 3-Month Efficacy Study

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Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear [ Time Frame: Baseline and Week 12 ]

The percentage of parabasal cell was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including the basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.

Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear [ Time Frame: Baseline and Week 12 ]

The percentage of superficial cell was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including the basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.

A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.

Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia [ Time Frame: Baseline and Week 12 ]

The severity of dyspareunia was evaluated by a questionnaire filled out by women. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.

Secondary Outcome Measures
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Change From Baseline to Week 12 in Severity of Vaginal Dryness [ Time Frame: Baseline and Week 12 ]

The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of vaginal dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.

Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions [ Time Frame: Baseline and Week 12 ]

To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were then analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.

Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity [ Time Frame: Baseline and Week 12 ]

To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was then analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.

Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness [ Time Frame: Baseline and Week 12 ]

To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, the vaginal epithelial surface thickness (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was then analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.

Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color [ Time Frame: Baseline and Week 12 ]

To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was then analyzed using the values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.

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Ages Eligible for Study:

40 Years to 75 Years (Adult, Senior)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Main Inclusion Criteria:

Postmenopausal women (hysterectomized or non-hysterectomized)

Women between 40 and 75 years of age.

Willing to participate in the study and sign an informed consent.

Women who have self-identified symptom(s)of vaginal atrophy.

For non-hysterectomized women, willing to have endometrial biopsy at screening and end of study.

Main Exclusion Criteria:

Undiagnosed abnormal genital bleeding.

Hypertension equal to or above 140/90 mm Hg.

The administration of any investigational drug within 30 days of screening visit.